Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)

NCT07243262 | Recruiting DMC

• 1 other identifier: 177986
• Study Type: observational
• Target: 6,079
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are developing a non-invasive breath test to help us detect pancreatic cancer earlier. The test detects small molecules called volatile organic compounds that are made by pancreatic cancers. Pancreatic cancer is a rare disease but patients are often diagnosed at a late stage because their symptoms are the same as those of many common illnesses. This makes it hard for doctors to know which patients need to be tested for pancreatic cancer. If the investigators find pancreatic cancer at a late stage, it reduces the number of treatment choices for patients. Our test could be offered to patients who are experiencing vague symptoms, which might be caused either by pancreatic cancer or a common illness. This test could help doctors to identify which of those patients may have pancreatic cancer, and ensure they get referred for specialised pancreatic cancer tests. The investigators hope that this will allow us to diagnose pancreatic cancer earlier, increasing treatment choices for patients and improving survival from pancreatic cancer. The investigators have previously conducted a study (VAPOR1) which collected breath samples from people with and without pancreatic cancer. When the investigators analysed these samples, they found that there is a difference in the volatile organic compounds breathed out by people who have pancreatic cancer compared to those that do not. The investigators used these 'markers' to develop a breath test to diagnose pancreatic cancer. In VAPOR2, the investigators will study our breath test in a much larger group of patients who have been referred for further investigations for potential underlying pancreatic cancer to see how accurately it can pick up the small percentage of people who have pancreatic cancer.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Keywords

Volatile organic compounds (VOCs); Breath analysis; Volatolomics; Validation; Early detection of cancer

Outcome Measures

Primary Outcomes (1)

• Validation of a triage breath test for detecting pancreatic ductal adenocarcinoma in 6079 participants referred from primary care with potential underlying pancreatic cancer.

  Estimation of sensitivity, specificity and numbers of false positives (with 95% confidence intervals) for a breath test to detect pancreatic ductal adenocarcinoma

  36 months

Secondary Outcomes (2)

• To test feasibility of the breath test in a large population

  36 months

• Economic modelling for scaling up breath testing into clinical practice.

  36 months

Study Arms (1)

VAPOR2 Participants

6079 participants above the age of 18 years with potential underlying pancreatic cancer referred from primary care according to urgent suspected cancer referral guidelines or referred directly to a pancreatic cancer multidisciplinary team meeting.

Diagnostic Test: Breath test

Interventions

Breath test DIAGNOSTIC_TEST

All participants will fast for a minimum of six hours prior to breath collection. For participants undergoing a procedure, breath samples must be obtained prior to administration of sedation, anaesthetic or other pharmacological agents. After providing written informed consent, participants will be asked to rinse their mouth with water and then provide a breath sample by exhaling into single-use breath collection bags via a mouthpiece that is subsequently sealed.

VAPOR2 Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants above the age of 18 years with potential underlying pancreatic cancer referred from primary care according to urgent suspected cancer referral guidelines will be invited to participate in the study. In addition, participants referred directly to a pancreatic cancer multidisciplinary team meeting will also be invited to participate in the study.

You may qualify if:

• Adult participants ≥ 18 years old
• Referral from primary care according to the urgent suspected cancer referral guidelines for potential underlying pancreatic cancer, or referral directly to a pancreatic cancer multidisciplinary team meeting

You may not qualify if:

• Previous pancreatic resection
• History of another cancer (other than non-melanoma skin cancers) within three years
• Pregnant participants (pregnancy status to be confirmed verbally with the participant)
• Participants with co-morbidities preventing breath collection
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• Imperial College London: lead
• Pancreatic Cancer UK: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Sherwood Forest Hospitals NHS Foundation Trust: collaborator
• Buckinghamshire Healthcare NHS Trust: collaborator
• Dorset County Hospital NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Kettering General Hospital NHS Foundation Trust: collaborator
• County Durham and Darlington NHS Foundation Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Betsi Cadwaladr University Health Board: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• North Tees and Hartlepool NHS Foundation Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Professor George B Hanna, PhD, FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Austin

CONTACT

+44 (0)20 7594 3653; vapor@imperial.ac.uk

Caoimhe Walsh, MBBS, MRCS

CONTACT

+44 (0)20 7594 3653; vapor@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)